By: Kathleen Williams, CPS Manager, Dan Ward, Product Manager
Recent updates to regulatory guidance (EU regulation 536/2014) mandate that clinical trial protocols include details regarding the tracing, storing, returning and destroying of all investigational products throughout the lifecycle of the trial. This mandate has moved accountability, reconciliation, returns and destruction from after thoughts to key considerations during the planning phase of a trial. End to end IP traceability arrangements need to be made and documented in trail protocols which in turn need IRB approval.
Almac’s ART™ feature can assist in organizing and defining these plans for trial leaders. ART™ makes planning for accountability, reconciliation and destruction seamless. It highlights all details needing consideration in advance and ensures the end-to-end traceability of investigational products is obtained.
What is ART™?
ART™ (Accountability & Reconciliation Tracking) is an electronic chain of custody solution that incorporates all IP events—from product release through to product destruction in a single system. It’s a single solution to comply thoroughly with GCPs and GMPs. ART™ features validations and flexible, configurable workflows that streamline the accountability and reconciliation processes.
Why do Almac’s clients select ART™?
The accountability and reconciliation process is known for being time-consuming and error-prone, two characteristics that result in it adding significantly to trial costs and timelines. The task of reconciling discrepancies in supply records that have accumulated over the course of a trial often adds as much as two years to the study closeout phase.
The effort to reconcile discrepancies before the destruction of kits at depots is magnified by the sites’ lack of compliance with accountability processes and tools. ART™ helps sites maintain compliance and complete records in order to significantly reduce discrepancies at the source.
Depots can now focus on managing their returns and destruction processes without the burden of identifying and resolving site issues. Supply managers can finally have real-time visibility into supply status and can monitor and report on compliance with Good Manufacturing Practices (GMP) without the need to construct complicated reports by collecting and assembling data from multiple sources.
What are the benefits?
ART™ helps sponsors and CROs realize time savings that come from easy setup, streamlined site operations, error reduction, and discrepancy resolution. Additionally, real-time validation checks at the time of dispensing and ongoing visibility to the condition of drug supplies throughout the supply chain improve compliance, reduce risk to patient safety, and safeguard against trial delays.
In fact, inadequate record keeping and inadequate accountability for IP are two of the most common issues cited in FDA warning letters.
Users can analyze and cross-reference patient records with supply records, all on a single screen. They can assess and report on the progress of the entire chain of custody, again in real time. And, they can perform root-cause analysis of issues relating to any IP event so they can address them as soon as possible.
What was being used before ART?
In many cases, accountability and reconciliation is still paper based, and in others it is supported by fragmented solutions that do not completely solve the problem. For example, accountability solutions that do not prevent discrepancies from creeping into data sets do little to improve reconciliation. Solutions that fail to link the drug assignment to the chain of custody records don’t provide a continuous, unbroken lineage of what was assigned, dispensed and returned, so they cannot confirm study compliance with regard to IP consumption.
In contrast, ART™ is integrated with the IXRS®3 system and provides visibility to, and an audit trail of, product conditions and movement throughout the trial. This improves patient safety, reduces trial risks, and strengthens monitoring and compliance while cutting costs and shortening timelines.
How do I fit ART to my standards?
ART™ is configurable to allow for 1 or 2 or even 3 step approval of accountability/reconciliation information. It can allow for correction of data during reconciliation or requesting for reaccounting. It can track consumption at the kit or unit (e.g. pill or other kit part) level. It can also be configured to report and alert for any discrepancies.
How can my trial achieve the best results?
Planning for accountability, reconciliation, returns and destruction of investigational product should be considered as important as planning for its release and distribution. Discussions related to this topic should be conducted as early in the lifecycle of a trial as possible. This will not only ensure compliance with EU regulation 536/2014, it will also save time and resources previously spent maintaining error-prone paper based systems.
During the design phase of your Almac IRT system, several considerations will be discussed in efforts to define and deliver an efficient vehicle to record the journey of all investigational product employed in a trial. Does IP need to be accounted for at a dosage unit level or a dispensing unit level? Will IP be returned and destroyed at sites? Or will IP need to be sent to a depot or other central location for destruction after being returned and accounted for at the site level? The Almac ART™ functionality is flexible enough to accommodate any combination of these scenarios.
ART™ guides users through steps to ensure complete collection of data and provides error-correction workflows— benefits that can only be realized when the system is used routinely. ART™ is best used as a trial progresses. It is not intended to be used sparingly or used just at study close out. Using ART™ as it is intended throughout the duration of a trial will result in accurate data collection and prevention of study close out delays.